510(k) · Cleared

Cleared

Posey Bed

K113357510(k) TraditionalCleared Mar 21, 2012128-day reviewClass I21 CFR 880.6760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

J. T. Posey Co. · OYS Patient Bed With Canopy/Restraints

Cleared on Mar 21, 2012 as substantially equivalent to K103817 (J. T. Posey Co., 2011) and 1 other predicate after a 128-day review. Its family tree reaches back 2 generations to 1997.

Decided: Mar 21, 2012
Review: 128 days
Class: Class I
Product code: OYS
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K963701 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK963701 Soma Safe EnclosureNova Technology Corp. · 1997
1 generation backK103817 Posey BedJ. T. Posey Co. · 2011
This deviceK113357 Posey BedJ. T. Posey Co. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K963701	Soma Safe Enclosure	Nova Technology Corp.	1997	—
−1	K103817	Posey Bed	J. T. Posey Co.	2011	—
0 (this device)	K113357	Posey Bed	J. T. Posey Co.	2012	—

FIG. 1 — Lineage of K113357, 1997–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OYS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K103817	Posey Bed Summary page 1 …lude home use, is the same unchanged device previously cleared by the FDA under K103817 via the 5 10(k) notification process, and is substantially equivalent for design and…	J. T. Posey Co.	2011	—
*	K963701	Soma Safe Enclosure Summary page 1 …used with an AC-powered adjustable hospital bed, for the home use environment, (K963 701). DEVICE DESCRIPTION: The Posey Bed 8070 is an enclosed bed canopy…	Nova Technology Corp.	1997	—

Also cleared against K103817: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 14.2 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K103817.

How does its category compare?

All OYS devices

OYS Patient Bed With Canopy/Restraints: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OYS

2in 2012

2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OYS

Too few OYS 510(k)s in any year since 2007 to give a median.

Recalls per year · OYS

1in 2022

2007high 1 (2022) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OYS

86in 2025

2007high 86 (2025) · low 0 (2007)2025

MAUDE reports naming product code OYS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	1
2011	1	—	0	0
2012	2	—	0	53
2013	0	—	0	80
2014	0	—	0	53
2015	0	—	0	9
2016	0	—	0	7
2017	0	—	0	6
2018	0	—	0	15
2019	0	—	0	16
2020	0	—	0	6
2021	0	—	0	5
2022	0	—	1 (1)	28
2023	0	—	0	7
2024	0	—	0	31
2025	0	—	0	86
2026	0	—	0	—

What is it indicated for?

The Posey Bed 8070 is a hospital bed, canopy, and mattress system designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit. The Posey Bed 8070 is a less restrictive alternative to physical restraints such as belts, vests, or jackets for patients at least 46 inches tall, weighing between 46 and 300 pounds. The Posey Bed 8070 is a restraint, and must be prescribed by a licensed physician that includes Rx use in the home environment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113357 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113357: Posey Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113357

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026